DeRoyal PROlign Back Brace - USER'S MANUAL USER'S MANUAL

Page 1
DEROYAL® PROLIGN® &
PRACTITIONER.
DEROYAL® PROLIGN® EXT
Powered by The Boa® System
RX ONLY FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE
SINGLE PATIENT USE
NON-STERILE
NOT MADE WITH NATURAL RUBBER LATEX
TO SALE OR USE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED
DEROYAL® PROLIGN® & DEROYAL® PROLIGN® EXT
Powered by The Boa® System
SINGLE PATIENT USE
NON-STERILE
NOT MADE WITH NATURAL RUBBER LATEX
RX ONLY FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE
TO SALE OR USE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED
IMPORTANT INFORMATION
Please read all warning and instructions before
use. Correct application is essential for proper product function and to reduce the risk of injury or re-injury inherent with the use of any brace.
INTENDED USE
The DeRoyal® PROlign® EXT powered by The Boa® System closure device is used for lower lumbar strains and sprains, proprioceptive feedback, postural control and reinforcement of proper body ergonomics.
CAUTIONS
• A physician or properly licensed practitioner (a
“prescriber”) who is familiar with the use and purpose of this brace must fit it to the user. The prescriber has a duty to provide wearing instructions and risks related to the use of this brace to other healthcare practitioners treating the users and the users themselves, including duration of use. The instructions provided in this sheet do not supersede hospital protocol or direct orders of the prescriber.
• Use only as directed by a medical professional.
• Prolonged usage can result in muscle atrophy in
the user. The user may require (1) a weaning period from the brace to build muscle strength (2) regular physical therapy exercises to maintain the strength of the back (3) a limitation on duration of use or (4) some combination of these.
• Inspect brace for damaged or missing components
before use.
• Discontinue use and consult your prescriber if the
brace or its components break or become damaged.
• Inspect the fit of the brace on the patient to ensure fit
is proper. DO NOT OVERTIGHTEN. Check regularly to ensure breathing is not compromised.
• Consult your prescriber immediately if you
experience sensation changes, unusual reactions, swelling or increased pain while using this brace. Discontinue use if pressure injuries develop.
• Wear clothing underneath this brace.
• Take special care if the user is diabetic or has poor circulation as these users may have decreased skin sensitivity and are at greater risk for poor peripheral circulation and pressure injuries.
SIZING
Circumferential waist measurement
X-Small 25” – 30” Small 30” – 35” Medium 35” – 40” Large 40” – 45”
0
1
2
3
4
5
6
7
8
9
X-Large 45” – 50” XX-Large 50” – 55”
INSTRUCTIONS FOR USE
NOTE: A shirt should be worn under this brace.
1. Prior to application,
pull out on both dials to release lacing.
2. While in a standing
position, place compression orthosis so that the plastic piece is
1
centered in the low back area. Secure side closure attachments.
3. Next, patient should lie
in a supine position with their knees comfortably bent (flexed) and their
2
hips parallel with their shoulders. Adjust the side closure attachments making sure they are symmetrical to one another and are equal distance from the center. NOTE: Posterior hook closures can also be adjusted.
IMPORTANT INFORMATION
Please read all warning and instructions before
use. Correct application is essential for proper product function and to reduce the risk of injury or re-injury inherent with the use of any brace.
INTENDED USE
The DeRoyal® PROlign® EXT powered by The Boa® System closure device is used for lower lumbar strains and sprains, proprioceptive feedback, postural control and reinforcement of proper body ergonomics.
CAUTIONS
• A physician or properly licensed practitioner (a
“prescriber”) who is familiar with the use and purpose of this brace must fit it to the user. The prescriber has a duty to provide wearing instructions and risks related to the use of this brace to other healthcare practitioners treating the users and the users themselves, including duration of use. The instructions provided in this sheet do not supersede hospital protocol or direct orders of the prescriber.
• Use only as directed by a medical professional.
• Prolonged usage can result in muscle atrophy in
the user. The user may require (1) a weaning period from the brace to build muscle strength (2) regular physical therapy exercises to maintain the strength of the back (3) a limitation on duration of use or (4) some combination of these.
• Inspect brace for damaged or missing components
before use.
• Discontinue use and consult your prescriber if the
brace or its components break or become damaged.
• Inspect the fit of the brace on the patient to ensure fit
is proper. DO NOT OVERTIGHTEN. Check regularly to ensure breathing is not compromised.
• Consult your prescriber immediately if you
experience sensation changes, unusual reactions, swelling or increased pain while using this brace. Discontinue use if pressure injuries develop.
• Wear clothing underneath this brace.
• Take special care if the user is diabetic or has poor circulation as these users may have decreased skin sensitivity and are at greater risk for poor peripheral circulation and pressure injuries.
SIZING
Circumferential waist measurement
0
1
X-Small 25” – 30” Small 30” – 35” Medium 35” – 40” Large 40” – 45”
2
3
4
5
6
7
8
9
X-Large 45” – 50” XX-Large 50” – 55”
INSTRUCTIONS FOR USE
NOTE: A shirt should be worn under this brace.
1. Prior to application,
pull out on both dials to release lacing.
2. While in a standing
position, place compression orthosis so that the plastic piece is
1
centered in the low back area. Secure side closure attachments.
3. Next, patient should lie
in a supine position with their knees comfortably bent (flexed) and their hips parallel with their
2
shoulders. Adjust the side closure attachments making sure they are symmetrical to one another and are equal distance from the center. NOTE: Posterior hook closures can also be adjusted.
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4. At each side of the compression orthosis, the patient will find a dial. While in the supine position, patient should push the dials in to engage, then turn knobs clockwise to tighten laces. Turn dials at the same time to ensure even compression. Turn dials until a comfortable level of compression is achieved. This compression is adjustable and can be released or tightened using the dials to accommodate different activity levels.
5. To remove the orthosis, pull out on dial to release compression, then remove the side hook closure attachment on one side.
Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 USA
888.938.7828 or 865.938.7828 www.deroyal.com
Part#0-1857 Revised 5/18
©2018 DeRoyal Industries, Inc.
All Rights Reserved. DeRoyal, the DeRoyal logo and Improving Care. Improving Business. are trademarks or registered trademarks of DeRoyal Industries, Inc.
The Boa System is a registered trademark of Boa Technology, Inc.
4. At each side of the compression orthosis, the patient will find a dial. While in the supine position, patient should push the dials in to engage, then turn knobs
4a4a
clockwise to tighten laces. Turn dials at the same time to ensure even compression. Turn dials until a comfortable level of compression is achieved. This compression is
4b4b
adjustable and can be released or tightened using the dials to accommodate different activity levels.
5. To remove the orthosis, pull out on dial to release compression, then remove the side hook closure attachment on one side.
Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 USA
888.938.7828 or 865.938.7828 www.deroyal.com
Part#0-1857 Revised 5/18
©2018 DeRoyal Industries, Inc.
All Rights Reserved. DeRoyal, the DeRoyal logo and Improving Care. Improving Business. are trademarks or registered trademarks of DeRoyal Industries, Inc.
The Boa System is a registered trademark of Boa Technology, Inc.
CARE INSTRUCTIONS
Remove inserts from front and back panels. Hand wash in cool water with a mild liquid soap. Do not use strong detergents or bleaches as they may be harmful to the material. Thoroughly rinse and blot excess water from support with a clean towel. Carefully stretch support into its normal shape and lay flat to dry. Ironing or automatic dryers are not recommended.
STORAGE AND TRANSPORT CONDITIONS
KEEP DRY
KEEP AWAY FROM SUNLIGHT
WARRANTY
DEROYAL® PRODUCTS ARE WARRANTED FOR NINETY (90) DAYS FROM THE DATE OF SHIPMENT FROM DEROYAL AS TO PRODUCT QUALITY AND WORKMANSHIP. DEROYAL’S
WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
CARE INSTRUCTIONS
Remove inserts from front and back panels. Hand wash in cool water with a mild liquid soap. Do not use strong detergents or bleaches as they may be harmful to the material. Thoroughly rinse and blot excess water from support with a clean towel. Carefully stretch support into its normal shape and lay flat to dry. Ironing or automatic dryers are not recommended.
STORAGE AND TRANSPORT CONDITIONS
KEEP DRY
KEEP AWAY FROM SUNLIGHT
WARRANTY
DEROYAL® PRODUCTS ARE WARRANTED FOR NINETY (90) DAYS FROM THE DATE OF SHIPMENT FROM DEROYAL AS TO PRODUCT QUALITY AND WORKMANSHIP. DEROYAL’S
WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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